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Photocoagulator And Accessories

FDA product code HQB · Class 2 · Ophthalmic

515
Registered devices
69
Adverse events
32
Recalls
30
510(k) clearances

Devices with this code

FCI directional LASER PROBE 25G IRIDEX/B&L — FCI S A S FCI 20 22Synergetics — SYNERGETICS USA, INC.NA — OPHTHALMED LLCNA — OPHTHALMED LLC23ga Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL LLCT.CURVED ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE — FCI S A S FCI 20 22CURVED LASER PROBE, 20G DORC — FCI S A S FCI 20 2225ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector — KATALYST SURGICAL LLCSynergetics — SYNERGETICS USA, INC.NA — OPHTHALMED LLCCURVED LASER PROBE, 23G IRIDEX/B&L — FCI S A S FCI 20 22VitreQ — Vitreq B.V.27GA Curved Laser Probe - Iridex — Peregrine Surgical, LlcSynergetics — SYNERGETICS USA, INC.NA — OPHTHALMED LLCSynergetics — SYNERGETICS USA, INC.Revolver Handle, 20ga Straight — KATALYST SURGICAL LLC25ga Bending Laser Probe - Alcon Compatible — Vortex Surgical, Inc.NA — OPHTHALMED LLCSynergetics — SYNERGETICS USA, INC.FCI directional LASER PROBE / EXTENDABLE 23G IRIDEX/B&L — FCI S A S FCI 20 22NA — OPHTHALMED LLCRevolver Handle, 27ga Tapered Curved — KATALYST SURGICAL LLCNA — OPHTHALMED LLC

Recent recalls

DateFirmReason
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of biob
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of biob
2025-11-19Vortex Surgical Inc.Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
2025-09-15Alcon Research LLCXXX
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.